Last Updated: May 1, 2026

Details for New Drug Application (NDA): 205583

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NDA 205583 describes DESVENLAFAXINE, which is a drug marketed by Alembic Pharms Ltd, Sun Pharm, Teva Pharms Usa, Actavis Labs Fl, Alembic, Hikma, Lupin Ltd, Macleods Pharms Ltd, Medicap Labs, Pharmobedient, Rubicon Research, Yichang Humanwell, and Zydus Pharms, and is included in fourteen NDAs. It is available from two suppliers. Additional details are available on the DESVENLAFAXINE profile page.

The generic ingredient in DESVENLAFAXINE is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

Summary for 205583

Tradename:	DESVENLAFAXINE
Applicant:	Sun Pharm
Ingredient:	desvenlafaxine fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Jan 28, 2014	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jan 28, 2014	TE:		RLD:	Yes

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